MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-10 for OPTI-FREE GP 0650288 manufactured by Alcon-fort Worth/alcon.
[2860496]
An optometrist reported a pt with severe keratitis after soaking her lenses for two days in this solution. The optometrist reported the pt's condition is improving with treatment. Add'l info was received from the optometrist who reported the diagnosis was toxic keratopathy which has resolved with treatment (with an unspecified medication). She reported the pt discontinued use of the product and contact lenses temporarily. In her opinion, it is unk if the device caused/contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
[10026034]
Eval summary: the product was not returned for analysis. Product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the mfg documentation. Add'l info was requested on (b)(6) 2012 by fax and mail. A completed questionnaire was received on (b)(6) 2012. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2012-00104 |
| MDR Report Key | 2696803 |
| Report Source | 05 |
| Date Received | 2012-08-10 |
| Date of Report | 2012-07-12 |
| Date of Event | 2012-07-11 |
| Date Mfgr Received | 2012-07-12 |
| Date Added to Maude | 2012-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | ALCON MANUFACTURING, LTD. |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134209 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 2099 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI-FREE GP |
| Generic Name | LENS CARE DISINFECTING SOLUTIONS |
| Product Code | MRC |
| Date Received | 2012-08-10 |
| Model Number | NA |
| Catalog Number | 0650288 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON-FORT WORTH/ALCON |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134209 US 76134 2099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-10 |